Cxbladder Detect was validated in a large, multicenter study published in the Journal of Urology. Cxbladder Detect outperformed NMP22TM BladderChekTM, NMP22TM ELISA, uRNA® and cytology as an effective adjunct to cystoscopy.1*

* NMP22 and BladderChek are trademarks of Alere (Brisbane, Australia). uRNA® was a forerunner of Cxbladder Detect (Pacific Edge Ltd, Dunedin, New Zealand).

Study background

  • This multicenter, prospective trial included a total 485 patients with a recent history of gross hematuria who were undergoing investigation for urothelial carcinoma (UC).
  • Eligible, consenting patients provided a freshly voided mid-stream urine sample before cystoscopy. The sample was then tested via Cxbladder Detect, uRNA, NMP22 ELISA and cytology at an independent, accredited testing laboratory. The NMP22 BladderChek test was performed at each study site.
  • The definitive presence of UC was confirmed by biopsy and histopathologic examination within 3 months of patients registering for the trial.
  • Patients without UC at 3 months, but who had a positive Cxbladder Detect test result, were followed-up at 1 year to determine disease and survival status.

cxbladder detect clinical study

Demographics

Participants were recruited from a population of patients presenting with macro-hematuria under cystoscopic investigation for urothelial carcinoma.

 

Malignant Diagnosis

Non-Malignant Diagnosis

Number

66

419

Age (median)

72 years

66 years

Gender 
Male
Female


92.4%
7.5%


78.3%
21.7%

Ethnicity 
Caucasian
Other


81.3%
18.7%


93.9%
6.1%

Current/ex-smokers

74%

58%

>6 months since hematuria

87%

74%

 

Study results

  • Outperformed comparative tests as an adjunct to cystoscopy.
  • Has a negative predictive value (NPV) of 97%.
  • Detected 100% of T1-T3, Tis and upper tract tumors.
  • Detected 97% of high-grade tumors.
  • Detected 68% of Ta tumors as compared to cytology at 35%.
  • Distinguished between low grade Ta tumors and other detected urothelial carcinomas with a sensitivity of 91% and specificity of 90%
  • Robust to BPH, cystitis/UTI, hematuria secondary to warfarin, prostatitis and urolithiasis.
  • Detected six urothelial carcinoma not identified by cystoscopy during the clinical work-up but confirmed at the 12 month follow-up:
    • 1 x T2 single renal pelvis.
    • 1 x Unk multiple high grade bladder tumors.
    • 1 x T2 single high grade bladder tumor.
    • 3 x Renal pelvic / distal uteric tumors (detected by CT; not path confirmed).
  • Has an overall sensitivity of 82% at 85% specificity
  • References

    1 O’Sullivan P, Sharples K, Dalphin M, et al. A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria. J Urol 2012;188:741–7

Find out more about the Cxbladder Detect clinical study.

Find out more about the Cxbladder Detect clinical study.
Find out more about the Cxbladder Detect clinical study.